Clinical Research Associate II
Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.
CLINICAL RESEARCH ASSOCIATE II
As an in-house Clinical Research Associate II (CRA) you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring and site management. You will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.
- Work closely with the Clinical Operations team to support all aspects of clinical studies
- Take a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plans
- Collaborate with cross functional team members to independently address routine study issues
- Assist with CRO and/or vendor oversight and management to ensure milestones are achieved
- Identify issues for escalation, participate in problem solving and implementation of risk mitigation
- Participate in departmental and corporate initiatives
- Perform co-monitoring visits with CRO, on an as needed basis, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
- Generate and maintain reports, listings, and trackers as needed
- Ensure close tracking of site enrollment and related metrics
- Establish and manage clinical trial master files (TMF).
- Complete other responsibilities as assigned
- BS or higher degree in science, nursing (RN or BSN), or equivalent discipline
- A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry
- Experience supporting studies in a fast-paced environment
- Success in working with CROs and vendors
- Excellent communication skills and ability to achieve milestones in a team environment
- Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience with managing studies in electronic data capture systems
- Experience with project, vendor, contract, and clinical research staff management
- Experience with Institutional Review Board (IRB) preparations and submission
- Ability to work independently, collaboratively and manage deadlines
- Experience with reviewing electronic medical records
- Knowledge in molecular diagnostics or laboratory skills is a plus
- Proficiency with Microsoft Word, Excel, PowerPoint and Project
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.